NF EN ISO 14971/A1

NF EN ISO 14971/A1

February 2004
Standard Cancelled

Medical devices - Application of risk management to medical devices - Amendment 1 : rationale for requirements

Le présent document donne la justification des exigences de la norme NF EN ISO 14971 de mai 2001. Ces justificatifs sont fournis à titre purement informatif.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2004

Number of pages

14 p.

Reference

NF EN ISO 14971/A1

ICS Codes

11.040.01   Medical equipment in general

Classification index

S99-211/A1

Print number

1 - 07/02/2005

International kinship

ISO 14971/A1:2003

European kinship

EN ISO 14971/A1:2003
Sumary
Medical devices - Application of risk management to medical devices - Amendment 1 : rationale for requirements

Le présent document donne la justification des exigences de la norme NF EN ISO 14971 de mai 2001. Ces justificatifs sont fournis à titre purement informatif.
Standard replaced by (1)
NF EN ISO 14971
June 2007
Standard Cancelled
Medical devices - Application of risk management to medical devices

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

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